BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RELOAD FOR ECHELON

    MDR report key: 2935212 · Received January 30, 2013

    Report

    Report Number
    3005075853-2013-00379
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    November 23, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE PAN DISLODGED. THE ANALYSIS RESULTS SHOWED THAT ONE ECR60W CARTRIDGE RELOAD INSTEAD OF THE REPORTED ECR60B WAS RECEIVED. THE RELOAD WAS RECEIVED UNFIRED; THE PAN WAS BENT AND PARTIALLY ENGAGED AT PROXIMAL END. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED CARTRIDGE. IN ADDITION IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BARIATRICS PROCEDURE, THE DEVICE WAS FOUND BENT IN THE PACKAGING. ANOTHER RELOAD WAS OPENED AND USED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41634 BLUE RELOAD FOR ECHELON STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CA0C

    Patients

    Seq Age Sex Outcome Treatment
    1